‫הודעה על החמרה (מידע בטיחות) בעלון לרופא‬
27/08/2015 ‫תאריך‬
Giroflox (133 31 30984) ‫שם התכשיר באנגלית ומספר הרישום‬
BioAvenir Ltd. ‫שם בעל הרישום‬
!‫טופס זה מיועד לפרוט ההחמרות בלבד‬
‫ההחמרות המבוקשות‬
‫טקסט חדש‬
Severe infections and mixed infections with
Gram-positive and anaerobic pathogens
Ciprofloxacin monotherapy is not suited for
treatment of severe infections and
infections that might be due to Grampositive or anaerobic pathogens. In such
infections ciprofloxacin must be coadministered with other appropriate
antibacterial agents.
Streptococcal Infections (including
Streptococcus pneumoniae)
Ciprofloxacin is not recommended for the
treatment of streptococcal infections due to
inadequate efficacy.
Genital tract infections
Epididymo-orchitis and pelvic inflammatory
diseases may be caused by
fluoroquinolone-resistant Neisseria
gonorrhoeae. Ciprofloxacin should be coadministered with another appropriate
antibacterial agent unless ciprofloxacinresistant Neisseria gonorrhoeae can be
excluded. If clinical improvement is not
achieved after 3 days of treatment, the
therapy should be reconsidered.
Intra-abdominal infections
There are limited data on the efficacy of
ciprofloxacin in the treatment of postsurgical intra-abdominal infections.
Travellers’ diarrhoea
The choice of ciprofloxacin should take into
account information on resistance to
ciprofloxacin in relevant pathogens in the
countries visited.
Infections of the bones and joints
Ciprofloxacin should be used in
combination with other antimicrobial agents
depending on the results of the
microbiological documentation.
Inhalational anthrax
Use in humans is based on in-vitro
susceptibility data and on animal
experimental data together with limited
human data. Treating physicians should
refer to national and /or international
consensus documents regarding the
treatment of anthrax.
‫טקסט נוכחי‬
…
…
Children and adolescents:
4 ‫ מתוך‬1 ‫עמוד‬
BPS-Safety update form SPC-01
‫פרק בעלון‬
Special warnings
and precautions
for use
Ciprofloxacin treatment should be initiated
only by physicians who are experienced in
the treatment of cystic fibrosis and/or
severe
infections
in
children
and
adolescents.
…
Musculoskeletal system:
… The risk of tendinopathy may be
increased in elderly patients or in patients
concomitantly treated with corticosteroids
(see section 4.8).
…
Central nervous system:
… Cases of polyneuropathy (based on
neurological symptoms such as pain,
burning, sensory disturbances or muscle
weakness, alone or in combination) have
been reported in patients receiving
ciprofloxacin.
Ciprofloxacin should be discontinued in
patients
experiencing
symptoms
of
neuropathy, including pain, burning,
tingling, numbness, and/or weakness in
order to prevent the development of an
irreversible condition (see section 4.8).
…
QT interval prolongation
Caution should be taken when using
fluoroquinolones, including ciprofloxacin, in
patients with known risk factors for
prolongation of the QT interval such as, for
example:
congenital long QT syndrome
concomitant use of drugs that are
known to prolong the QT interval
(e.g. Class IA and III antiarrhythmics, tricyclic
antidepressants, macrolides,
antipsychotics)
uncorrected electrolyte imbalance
(e.g. hypokalaemia,
hypomagnesaemia)
cardiac disease (e.g. heart failure,
myocardial infarction, bradycardia)
Elderly patients and women may be more
sensitive to QTc-prolonging medications.
Therefore, caution should be taken when
using fluoroquinolones, including
ciprofloxacin, in these populations.
(See section 4.2 Elderly, section 4.5,
section 4.8, section 4.9).
…
Methotrexate
The concomitant use of ciprofloxacin with
methotrexate is not recommended (see
section 4.5).
…
…
…
Methotrexate
… The concomitant use is not
recommended (see section 4.4).
4 ‫ מתוך‬2 ‫עמוד‬
BPS-Safety update form SPC-01
Interactios with
other medicinal
products and
…
other forms of
interaction
Ropinirole
… Monitoring of ropinirole-related side
effects and dose adjustment as appropriate
is recommended during and shortly after
co-administration with ciprofloxacin (see
section 4.4).
Clozapine
… Clinical surveillance and appropriate
adjustment of clozapine dosage during and
shortly after coadministration with
ciprofloxacin are advised (see section 4.4).
Ciprofloxacin, like other fluoroquinolones,
should be used with caution in patients
receiving drugs known to prolong the QT
interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants,
macrolides, antipsychotics) (see section
4.4).
The most commonly reported adverse drug
reactions (ADRs) are nausea, diarrhoea,
vomiting, transient increase in
transaminases, rash, and injection and
infusion site reactions.
…
Infections and infestations
Rare: Antibiotic associated colitis (very
rarely with possible fatal outcome) (see
section 4.4)
Blood and the lymphatic system
disorders:
Rare: Neutropenia
Very rare: Bone marrow depression (lifethreatening)
Psychiatric disorders:
Uncommon: Psychomotor hyperactivity /
agitation
Rare: Confusion and disorientation
Nervous system disorders:
Rare: Par- and Dysaesthesia,
Hypoaesthesia, Vertigo
Frequency not known: Peripheral
neuropathy (see section 4.4)
Ear and labyrinth disorders:
Rare: hearing loss
hearing impaired
Vascular disorders:
Rare: Hypotension
Hepato-biliary disorders:
Rare: Hepatitis
Skin and subcutaneous tissue
disorders:
Very rare: Petechiae
Stevens-Johnson syndrome (potentially
life-threatening), Toxic epidermal
necrolysis (potentially life-threatening)
Musculoskeletal, connective tissueand
bone disorders:
Uncommon: Musculoskeletal pain (e.g.
extremity pain, back pain, chest pain)
Adverse reactions have been
reported in 5-14% of patients
receiving ciprofloxacin. The most
frequent adverse effects involve
the gastro-intestinal tract and the
central nervous system.
…
Nervous system disorders:
Rare: Paraesthesia
Ear and labyrinth disorders:
Rare: Transient hearing loss
Skin and subcutaneous tissue
disorders:
Very rare: Stevens-Johnson
syndrome, epidermal necrolysis
(Lyell Syndrome)
4 ‫ מתוך‬3 ‫עמוד‬
BPS-Safety update form SPC-01
Undesirable
effects
Rare: Increased muscle tone and cramping
Very rare: Muscular weakness,
Exacerbation of symptoms of myasthenia
gravis (see section 4.4)
General disorders and administration
site conditions:
Common: Injection and infusion site
reactions (only intravenous administration)
Rare: Sweating
Investigations:
Rare: increased amylase
The following undesirable effects have a
higher frequency category in the
subgroups of patients receiving
intravenous or sequential (intravenous to
oral) treatment:
Common
Uncommon
Rare
Vomiting, Transient
increase in
transaminases, Rash
Thrombocytopenia,
Thrombocytaemia,
Confusion and
disorientation,
Hallucinations, Parand dysaesthesia,
Seizures, Vertigo,
Visual disturbances,
Hearing loss,
Tachycardia,
Vasodilatation,
Hypotension,
Transient hepatic
impairment,
Cholestatic icterus,
Renal failure,
Oedema
Pancytopenia, Bone
marrow depression,
Anaphylactic shock,
Psychotic reactions,
Migraine, Olfactory
nerve disorders,
Hearing impaired,
Vasculitis,
Pancreatitis, Liver
necrosis, Petechiae,
Tendon rupture
Reversible renal toxicity has been reported
Overdose
.‫מצ"ב העלון שבו מסומנים ההחמרות המבוקשות על רקע צהוב‬
‫ יש לסמן רק תוכן מהותי‬.)‫שינויים שאינם בגדר החמרות סומנו (בעלון) בצבע שונה (טקסט ירוק‬
.‫ולא שינויים במיקום הטקסט‬
27/08/2015 ‫הועבר בדואר אלקטרוני בתאריך‬
4 ‫ מתוך‬4 ‫עמוד‬
BPS-Safety update form SPC-01